8月龄首剂接种国产麻疹腮腺炎风疹联合减毒活疫苗的安全性及免疫原性观察

Safety and Immunogenicity of Domestic Combined Live Attenuated Measles,Mumps and Rubella Vaccine Injected With 8-month Infants at the First Dose

目的观察国产麻疹腮腺炎风疹联合减毒活疫苗（MMR）对8月龄婴儿的安全性及免疫原性。方法选择8～9月龄未接种过麻疹、腮腺炎、风疹疫苗的健康儿童共77名，随机分别接种国产MMR疫苗40名和国产对照麻疹风疹减毒活疫苗（MR）37名，观察接种后的安全性及免疫原性。采用ELISA法检测血清中的麻疹、腮腺炎、风疹的IgG抗体水平。结果77名观察对象全身反应率为6．49％，未观察到局部反应。2组疫苗免疫后麻疹抗体阳转率均为100％，MMR组腮腺炎抗体阳转率为87．50％，风疹抗体阳转率分别为82．50％和86．49％。2组疫苗免疫后麻疹抗体平均浓度分别为1714．63、和1117．54IU／ml，抗体平均增长约627．72和12870．35倍；MMR组腮腺炎抗体平均浓度为3313．8IU／ml，抗体平均增长分别约24．32倍；风疹抗体平均浓度分别为40．63和44．22IU／ml，抗体平均增长分别约40．63和44．22倍。2组问麻疹和风疹抗体阳转率、抗体平均浓度和平均增长倍数差异均无统计学意义（P〉0．05）；麻疹、风疹抗体同时阳性率差异无统计学意义（P〉0．05）。结论MMR疫苗对8月龄婴儿的安全性、免疫原性良好且能提供额外的腮腺炎抗体。

Objective To observe the safety and immunogenicity of domestic combined live attenuated measles, mumps and rubella （MMR） vaccine in 8 - month infants. Methods A total of 77 healthy infants unimmunized with MMR previously, aged 8 -9 months, were randomly divided into MMR group immunized with MMR vaccines manufactured by the domestic and control groups immunized with MR vaccines manufactured by the domestic, then safety and immunogenicity were observed. The IgG levels against measles, mumps and rubella in sera of the infants were determined by ELISA. Results The systemic rates of the 77 immunized infants were 6.49% and the local adverse was reaction unobserved. The positive conversion rates of antibody against measles in MMR and control groups were 100% , while those against mumps in MMR was 87.50% , those against rubella were 82.50% and 86.49%, respectively. The mean concentrations of antibody against measles in the two groups were 1714.63 and 1117.54 IU/ml respectively, which increased by about 627.72 and 12870.35 folds in average; while MMR against mumps were 3313.81 IU/ml, which increased by about 24. 32 folds in average respectively, and those against rubella were 40. 63 and 44.22 IU/ml respectively, increased by about 40.63 and 44.22 folds in average, respectively. No statistical differences were observed in the positive conversion rates. The mean concentrations as well as their mean increasing folds of antibodies against measles and rubella showed no statistical difference in various groups （ P 〉 0. 05 ）. No statistical differences were observed in the dual positive conversion rates of the antibody against measles and rubella in the two groups （P 〉 0.05 ）. Conclusion MMR vaccines are of high safety and immunogenicity to control groups immunized with MR vaccines, and exhibit extra antibody against mumps.